Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
36673–36696 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 2014
EIDON
K142047 · MYC
Centervue S.P.A.
Ophthalmic · 107d
Cleared Nov 12, 2014
Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator...
K142301 · DRE
Cook Vascular, Inc.
Cardiovascular · 86d
Cleared Nov 12, 2014
AngioVac Cannula
K142593 · DWF
AngioDynamics, Inc.
Cardiovascular · 58d
Cleared Nov 12, 2014
Zimmer Plates and Screws (ZPS), Forte Screws
K142836 · HRS
Zimmer, Inc.
Orthopedic · 43d
Cleared Nov 12, 2014
neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US
K142903 · GCJ
Neosurgical, Ltd.
General & Plastic Surgery · 37d
Cleared Nov 12, 2014
20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205)
K143076 · PGY
Jvckenwood Corporation
Radiology · 16d
Cleared Nov 12, 2014
Coronis Fusion 4MP LED
K143157 · PGY
Barco N.V.
Radiology · 9d
Cleared Nov 10, 2014
YEESCOPE LARYNGOSCOPES
K140951 · CCW
Yeescope Pty. , Ltd.
Anesthesiology · 210d
Cleared Nov 10, 2014
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
K140961 · KTT
Stryker Trauma AG
Orthopedic · 209d
Cleared Nov 10, 2014
KIMGUARD SMART-FOLD STERILIZATION WRAP
K140963 · FRG
Kimberly-Clark Corp.
General Hospital · 209d
Cleared Nov 10, 2014
DENALI 501CEMENT
K141503 · EMA
Denali Corporation
Dental · 157d
Cleared Nov 10, 2014
LEAF PATIENT MONITORING SYSTEM
K141877 · KMI
Leaf Healthcare, Inc.
General Hospital · 122d
Cleared Nov 07, 2014
PANTHEON ELECTROSTIMULATOR
K133980 · BWK
Pantheon Research
Neurology · 315d
Cleared Nov 07, 2014
CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4...
K140389 · FRO
Entrotech Life Sciences, Inc.
General & Plastic Surgery · 266d
Cleared Nov 07, 2014
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
K140732 · GEX
Candela Corp.
General & Plastic Surgery · 228d
Cleared Nov 07, 2014
INNOVASIS CRANIAL SYSTEM
K141644 · GWO
Innovasis, Inc.
Neurology · 141d
Cleared Nov 07, 2014
PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
K141771 · NYI
Nanostring Technologies, Inc.
Pathology · 129d
Cleared Nov 07, 2014
MIDLINE II TI
K141942 · OVD
Centinel Spine, Inc.
Orthopedic · 113d
Cleared Nov 07, 2014
PUREFILL OXYGEN COMPRESSOR
K141967 · CAW
Inovo, Inc.
Anesthesiology · 109d
Cleared Nov 07, 2014
ENCORE HUMERAL SHOULDER STEM
K141990 · PHX
Encore Medical, L.P.
Orthopedic · 108d
Cleared Nov 07, 2014
SMR 40MM GLENOSPHERE
K142139 · PHX
Lima Corporate S.P.A.
Orthopedic · 94d
Cleared Nov 07, 2014
Power Twin21-50/Power Twin21-100
K142215 · ILY
Livetec GmbH
Physical Medicine · 87d
Cleared Nov 07, 2014
EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments
K142550 · JWH
Microport Orthopedics, Inc.
Orthopedic · 58d
Cleared Nov 07, 2014
SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING
K143001 · FRO
Argentum Medical
General & Plastic Surgery · 21d